Determine Effect of Urological Malpractice During Covid 19 on Patient ComplicationsNCT05839249
The Impact of Covid 19 Pandemic on Ureteric Stents Complications.
An observational study of Determine Effect of Urological Malpractice During Covid 19 on Patient Complications, run by South Valley University at 1 site in Egypt.
Trial summary
The pandemic of coronavirus disease 2019 (COVID-19) has serious implications on urology practice and raises particular questions for urologists about the management of different conditions. It was recommended to cancel most of the elective urological surgeries. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Determine Effect of Urological Malpractice During Covid 19 on Patient Complications
- What is being tested?
- JJ urological stents
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients performing JJ stent placement from January 2020 to December 2021
Who may be able to join
- all patients performing JJ stent placement during Covid 19 pandemics
Who cannot join
- Patients refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
The pandemic of coronavirus disease 2019 (COVID-19) has serious implications on urology practice and raises particular questions for urologists about the management of different conditions. It was recommended to cancel most of the elective urological surgeries. (1) The least invasive intervention modalities that can be completed in local or regional anesthesia will serve the best interest of patients and urologists. 10 14 Endoscopic surgery is considered relatively safe.(2) After end of pandemic we facing complication of this era, one of most common complication was JJ stents complications as most of patient and doctors prefers to defer most of elective management by just JJ insertion and postpone definitive treatment. (3) In this study we discuss retrospectively the complication of JJ stenting during Covid 19 pandemic.
Read the detailed description
Type of the study: retrospective clinical study
- Study Setting: Qena University Hospital 3- Study subjects:
- Inclusion criteria: all patients performing JJ stent placement during Covid 19 pandemics b. Exclusion criteria: Patients refuse to participate in this study c. Sample Size Calculation: all patients performing JJ stent placement from March 2020 to December 2021
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
- Medical history
- Complete physical examination.
- All patents presented was investigated by
- Abdominal U.S
- Plain X Ray
- Non contrast CT
- Serum Creatinine
- Urine Analysis
- Research outcome measures:
- Primary (main): determine effect of urological malpractice during Covid 19 on patient complications
- Secondary (subsidiary): determine JJ stent complications during Covid 19 pandemics
- Being tested
- JJ urological stents
- Keywords
- urological stents , COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JJ urological stentsOther
recording complications of JJ stents during COVID19 pandemics
What is being measured
The primary outcome is the main question the study is designed to answer.
jj stents complications during covid 19 pandimics
determine effect of urological malpractice during Covid 19 on patient complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jan 2020
- Primary completion1 Apr 2023
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine Effect of Urological Malpractice During Covid 19 on Patient ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa AbdelRazek, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839249
- Sponsor's protocol ID
- SVU/MED/URO016/2.23.4.539
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Covid 19 Pandemic on Ureteric Stents Complications.
- ClinicalTrials.gov ID
- NCT05839249
- Acronym / sponsor ID
- SVU/MED/URO016/2.23.4.539
- Keywords
- urological stents , COVID19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pandemic of coronavirus disease 2019 (COVID-19) has serious implications on urology practice and raises particular questions for urologists about the management of different conditions. It was recommended to cancel most of the elective urological surgeries. (1) The least invasive intervention modalities that can be completed in local or regional anesthesia will serve the best interest of patients and urologists. 10 14 Endoscopic surgery is considered relatively safe.(2) After end of pandemic we facing complication of this era, one of most common complication was JJ stents complications as most of patient and doctors prefers to defer most of elective management by just JJ insertion and postpone definitive treatment. (3) In this study we discuss retrospectively the complication of JJ stenting during Covid 19 pandemic.
Detailed description
Type of the study: retrospective clinical study
- Study Setting: Qena University Hospital 3- Study subjects:
- Inclusion criteria: all patients performing JJ stent placement during Covid 19 pandemics b. Exclusion criteria: Patients refuse to participate in this study c. Sample Size Calculation: all patients performing JJ stent placement from March 2020 to December 2021
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
- Medical history
- Complete physical examination.
- All patents presented was investigated by
- Abdominal U.S
- Plain X Ray
- Non contrast CT
- Serum Creatinine
- Urine Analysis
- Research outcome measures:
- Primary (main): determine effect of urological malpractice during Covid 19 on patient complications
- Secondary (subsidiary): determine JJ stent complications during Covid 19 pandemics
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients performing JJ stent placement from January 2020 to December 2021
Key inclusion criteria (1 listed)
- all patients performing JJ stent placement during Covid 19 pandemics
Key exclusion criteria (1 listed)
- Patients refuse to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JJ urological stentsrecording complications of JJ stents during COVID19 pandemics | Other | – |
Primary outcome
jj stents complications during covid 19 pandimics
Time frame: 3 years
determine effect of urological malpractice during Covid 19 on patient complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determine Effect of Urological Malpractice During Covid 19 on Patient Complications, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
jj stents complications during covid 19 pandimics (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.